On March 21, 2019, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma.
The statement alerts health-care professionals and patients about the suspension of the BELLINI trial (ClinicalTrials.gov identifier NCT02755597) of bortezomib and low-dose dexamethasone with or without venetoclax in patients with relapsed and refractory multiple myeloma.
Interim results from the trial demonstrate an increased risk of death for patients receiving venetoclax. Other multiple myeloma clinical trials of venetoclax and other combinations were also suspended. The FDA’s safety alert does not apply to the approved indications for venetoclax, as the safety and efficacy of using venetoclax for approved, on-label uses have been established.